The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
A roundup of news from Japan (Lilly, Daiichi Sankyo, Novartis), the UK (AstraZeneca, GSK), and the US (BMS, Novartis, Vedere Bio, Nostrum Laboratories).
Japan
Novartis Gets OK for CAR-T Cell Therapy Mfg Site in JapanNovartis has received approval...
Johnson & Johnson (J&J) and AstraZeneca have announced plans to resume clinical trials in the US for their respective COVID-19 vaccine candidates after earlier pausing trials due to an unexpected illness of a study participant in their...
The US Food and Drug Administration (FDA) has approved Gilead Sciences’ antiviral drug, Veklury (remdesivir), for treating hospitalized COVID-19 patients, making it the first drug in the US to receive marketing authorization by the FDA to treat...
The latest on manufacturing and potential treatments for COVID-19 with news from Sanofi, GSK, Novartis, Takeda, BI, Moderna, Regeneron, and Novavax.
Manufacturing and supply news for COVID-19 vaccines and drugs
Sanofi, GSK To Supply 200 M Doses...
Eli Lilly and Company has entered into an agreement for $375 million with the US government to supply 300,000 vials of LY-CoV555 (bamlanivimab) (700 mg), the company’s investigational monoclonal antibody for treating COVID-19.
The supply agreement...
Gilead Sciences has completed its previously announced acquisition of Immunomedics, a Morris Plains, New Jersey-based clinical-stage biopharmaceutical company focused on antibody-drug conjugates (ADCs), for approximately $21 billion. Gilead had...
Bayer has agreed to acquire Asklepios BioPharmaceutical (AskBio), a Research Triangle Park, North Carolina-based clinical-stage gene-therapy company, in a deal worth up to $4 billion ($2 billion upfront and up to $2 billion in milestone...
The latest on manufacturing and potential treatments for COVID-19 with news from AstraZeneca, Moderna, Roche, J&J, BMS, AbbVie, Sanofi, Fujifilm, and others.
Manufacturing and supply news for COVID-19 vaccines and drugs
AstraZeneca in...
A roundup of news from Australia (Australian government), Canada (Roche), UK (UCB), and the US (Astellas, iota Biosciences).
Australia
Australian Gov’t Issues $355,000 in Funding for Clinical Trial MfgThe Australian government has provided...
Purdue Pharma has reached a settlement of $8.3 billion with the US Department of Justice (DOJ) to resolve multi-year civil and criminal investigations into the company’s past marketing practices related to its opioid medicines.
Under the...
Albert Bourla, Chairman and CEO of Pfizer, issued an open letter on October 16, 2020 to update the development timelines of its lead COVID-19 vaccine candidate, which the company is developing with its partner, BioNTech, a Mainz, Germany-based...
Eli Lilly and Company has agreed to acquire Disarm Therapeutics, a Cambridge, Massachusetts-based biopharmaceutical company, in a $1.36-billion deal ($135 million upfront and $1.225 billion in milestones).
Disarm Therapeutics is a start-up company...
A roundup of news from the US (Regeneron, Seattle Genetics).
US
FDA OKs Regeneron’s Ebola Drug The US Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals’ Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for treating...
Merck & Co. reports it will construct a new manufacturing facility in North Carolina to expand its production capacity for TICE BCG, a medicine containing live, attenuated mycobacteria, and used for treating certain forms of bladder...
The latest on manufacturing and potential treatments for COVID-19 with news from Lilly, AbbVie, BI, Gilead Sciences, Pfizer, AstraZeneca, CSL, Takeda and others.
Lilly Comments on COVID Trial Enrollment Pause for Bamlanivimab Eli Lilly and Company...